CER-S

K243312 · Cardiocalm Srl · DQK · Feb 20, 2025 · Cardiovascular

Device Facts

• Record ID: K243312
• Device Name: CER-S
• Applicant: Cardiocalm Srl
• Product Code: DQK · Cardiovascular
• Decision Date: Feb 20, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1425
• Device Class: Class 2
• Attributes: Software as a Medical Device, Pediatric

Intended Use

CER-S is a medical device stand-alone software intended for the analysis, editing, review and reporting of continuous ECG digital recordings, to support the clinician in the interpretation of the trace and the diagnosis of cardiac rhythm disorders in adult and pediatric patients. CER-S is intended for use in clinical and hospital settings only by qualified medical personnel or adequately trained professional personnel working under the supervision and responsibility of a clinician. Users must undergo a thorough software training before using the medical device. This device does not provide an automated interpretation and is not intended for use as the only diagnostic tool.

Device Story

CER-S is a PC-based SaMD for continuous ECG analysis; inputs digital ECG recordings from Holter, event recorders, or 12-lead ambulatory devices. Software modules perform beat detection, classification, arrhythmia detection, and rhythm analysis; provides interactive viewers for editing beats, rhythm annotations, and noise windows. Clinicians use the system to generate Holter-like reports and export data in ISHNE or aECG FDA HL7 XML formats. Used in clinical/hospital settings by trained personnel under clinician supervision. Output supports clinical diagnosis of rhythm disorders; does not provide automated interpretation. Benefits include improved workflow for ECG review and diagnostic support.

Clinical Evidence

No clinical data. Substantial equivalence demonstrated via bench testing, including ECG performance testing (IEC 60601-2-47, IEC 60601-2-25), software lifecycle validation (IEC 62304), usability engineering (IEC 62366-1), and risk management (ISO 14971).

Technological Characteristics

PC-based SaMD running on Windows OS. Performs ECG signal processing, beat/rhythm detection, and template management. Connectivity via file export (ISHNE, HL7 XML). Software developed per IEC 62304; usability per IEC 62366-1. Requires conductive paste/gel electrodes; supports specific patch configurations (two-electrode, three-electrode triangular, three-electrode T-shaped).

Indications for Use

Indicated for adult and pediatric patients, including newborns (QRS detection only), requiring evaluation of cardiac arrhythmias, transient myocardial ischemia, pacemaker function (if pacing detection available), or HRV. Contraindicated for use with dry or dry/metal electrodes; requires conductive paste/gel electrodes.

Regulatory Classification

Identification

A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.

Predicate Devices

• CER-S (K213861)

Submission Summary (Full Text)

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February 20, 2025

CardioCalm Srl Fabio Badilini President Corso Martiri della Libertà, nr. 40 Montichiari, BS 25018 Italy

Re: K243312

Trade/Device Name: CER-S Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DQK Dated: January 22, 2025 Received: January 22, 2025

Dear Fabio Badilini:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

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Sincerely,

## Jennifer W. Shih -S

Jennifer Kozen Assistant Director Division of Cardiac Electrophysiology, Diagnostics, and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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### Indications for Use

| Submission Number (if known) | K242242 |
|------------------------------|---------|
|------------------------------|---------|

K243312 Device Name

CER-S

Indications for Use (Describe)

CER-S is a medical device stand-alone software intended for the analysis, editing, review and reporting of continuous ECG digital recordings, to support the clinician in the interpretation of the trace and the diagnosis of cardiac rhythm disorders in adult and pediatric patients.

CER-S is intended for use in clinical and hospital settings only by qualified medical personnel or adequately trained professional personnel working under the supervision and responsibility of a clinician. Users must undergo a thorough software training before using the medical device. This device does not provide an automated interpretation and is not intended for use as the only diagnostic tool.

CER-S analysis provides indications for evaluation of:

- · Patients with rhythm disturbances (cardiac arrhythmias),
- · Patients with transient myocardial ischemia,
- · Patients with pacemaker (only if pacing detection is available from the input recording),
- · Patients needing HRV evaluation.
- · Newborn patients limited to QRS detection.

Type of Use (Select one or both, as applicable)

> Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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| | | | (as required by 21 CFR 807.92) | | |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------|----------------------------------------------------------------------------------|--|
| Submitter | | CardioCalm Srl | | | |
| Corso Martiri della Libertà, nr. 40 | | | | | |
| 25018 Montichiari (BS) | | | | | |
| Telephone | + 39 030 9650745 | | | | |
| Fax | | + 39 030 9650572 | | | |
| | | | | | |
| Contact Person | Fabio Badilini | | | | |
| President & Legal Representative | | | | | |
| Address | Corso Martiri della Libertà, nr. 40 | | | | |
| Telephone | + 39 030 9650745 | | | | |
| Fax | | + 39 030 9650572 | | | |
| Email | [e-mail] | | | | |
| | | | | | |
| Date Prepared | 21/10/2024 | | | | |
| | | | | | |
| Trade Name | CER-S | | | | |
| Common Name | Continuous ECG Recording - Suite | | | | |
| Panel Code | Cardiovascular/74 | | | | |
| Classification Name | Computer diagnostic, programmable | | | | |
| Class | Class II | | | | |
| Regulation Number | 21 CFR 870.1425 | | | | |
| Regulation Description | Programmable diagnostic computer | | | | |
| Product Code | DQK | | | | |
| | | | | | |
| Name of Predicate Device | | 510(k) # | Manufacturer | | |
| | | | | | |
| CER-S | | K213861 | CardioCalm Srl | | |
| | | | | | |
| Reason for<br>Submission | Intention to introduce into commercial distribution a device, CER-S, that has undergone significant<br>changes that could affect the substantial equivalence with the predicate device.…